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TOPLINE:
Non-operative management achieved 95% distant relapse-free survival at 30 months in patients with stage II-III rectal cancer showing a clinical complete response to total neoadjuvant therapy, while maintaining successful salvage surgery options among 15% of those who experienced local regrowth according to a phase 2 trial.
METHODOLOGY:
- Researchers conducted an investigator-driven, multicentre, single-arm, phase 2 trial enrolling 180 patients (median age, 62 years; 44% women) with stage II-III adenocarcinoma of the lower-to-middle rectum across four cancer centres in Italy from June 2018 to August 2023.
- Treatment consisted of induction chemotherapy with 4 cycles of capecitabine (1000 mg/m2 orally twice daily on days 1-14 every 3 weeks) and oxaliplatin (130 mg/m2 intravenously on day 1 every 3 weeks), followed by chemoradiotherapy with 50-54 Gy in 25 fractions for 5 weeks.
- The analysis included 179 evaluable patients: 47 (26%) who achieved a clinical complete response were assigned to nonoperative management, 107 (60%) underwent surgery after therapy, and 18 (10%) underwent surgery after study discontinuation.
- The primary outcome was 30-month distant relapse-free survival in the non-operative management group, and secondary outcomes included local relapse-free or regrowth-free survival (local regrowth after non-operative management and local relapse after surgery).
TAKEAWAY:
- After a median follow-up of 35 months, 30-month distant relapse-free survival reached 95% in the non-operative management group vs 74% in the surgery group and 74% in the overall population.
- Among patients undergoing non-operative management, 15% experienced tumour regrowth in the rectal wall within 2 years, corresponding to a 2-year risk for local regrowth of 17%, and cumulative risks for local relapse were 11% at 2 years and 16% at 3 years among those in the surgery group.
- The most common adverse events of grade 3-4 were diarrhoea (4%), lymphopenia (4%), and neutropenia (4%). Overall, 17% of patients had a serious adverse event, with bowel obstruction (4%) and thromboembolism (3%) being the most common adverse events.
- Circulating tumour DNA positivity after total neoadjuvant therapy showed significant prognostic value, with the positive status associated with worse distant relapse-free survival (P = .0032) and progression-free survival (P = .0028) among patients in the non-operative management group.
IN PRACTICE:
“Nonoperative management ensures excellent distant disease control with organ preservation after clinical complete response,” the authors wrote. “As a watch-and-wait approach becomes a recognised standard in international guidelines, the integration of ctDNA [circulating tumour DNA] and possibly other novel biomarkers, adds a crucial dimension to risk stratification and underscores the potential for personalised treatment approaches,” they added.
SOURCE:
This study was led by Alessio Amatu, MD, and Giorgio Patelli, MD, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy. It was published online in The Lancet Oncology .
LIMITATIONS:
This study was powered only to estimate 30-month distant relapse-free survival for the non-operative management group, potentially limiting statistical power for subgroup and molecular analyses. The single-arm design without randomisation did not directly address whether rectal surgery might provide added value in cases of clinical complete response. The specific induction-based total neoadjuvant therapy strategy used might not have fully reflected evolving practices. Additionally, the racial homogeneity of the study population limited generalisability beyond predominantly White populations.
DISCLOSURES:
This study was funded by Fondazione AIRC ETS, Fondazione Oncologia Niguarda ETS, Grande Ospedale Metropolitano Niguarda, Ministero della Salute, and AIRC 5xMille 2018. Several authors reported receiving grants or honoraria and having other ties with various sources. Full disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.A version of this article first appeared on Medscape.com.
TOPLINE:
Non-operative management achieved 95% distant relapse-free survival at 30 months in patients with stage II-III rectal cancer showing a clinical complete response to total neoadjuvant therapy, while maintaining successful salvage surgery options among 15% of those who experienced local regrowth according to a phase 2 trial.
METHODOLOGY:
- Researchers conducted an investigator-driven, multicentre, single-arm, phase 2 trial enrolling 180 patients (median age, 62 years; 44% women) with stage II-III adenocarcinoma of the lower-to-middle rectum across four cancer centres in Italy from June 2018 to August 2023.
- Treatment consisted of induction chemotherapy with 4 cycles of capecitabine (1000 mg/m2 orally twice daily on days 1-14 every 3 weeks) and oxaliplatin (130 mg/m2 intravenously on day 1 every 3 weeks), followed by chemoradiotherapy with 50-54 Gy in 25 fractions for 5 weeks.
- The analysis included 179 evaluable patients: 47 (26%) who achieved a clinical complete response were assigned to nonoperative management, 107 (60%) underwent surgery after therapy, and 18 (10%) underwent surgery after study discontinuation.
- The primary outcome was 30-month distant relapse-free survival in the non-operative management group, and secondary outcomes included local relapse-free or regrowth-free survival (local regrowth after non-operative management and local relapse after surgery).
TAKEAWAY:
- After a median follow-up of 35 months, 30-month distant relapse-free survival reached 95% in the non-operative management group vs 74% in the surgery group and 74% in the overall population.
- Among patients undergoing non-operative management, 15% experienced tumour regrowth in the rectal wall within 2 years, corresponding to a 2-year risk for local regrowth of 17%, and cumulative risks for local relapse were 11% at 2 years and 16% at 3 years among those in the surgery group.
- The most common adverse events of grade 3-4 were diarrhoea (4%), lymphopenia (4%), and neutropenia (4%). Overall, 17% of patients had a serious adverse event, with bowel obstruction (4%) and thromboembolism (3%) being the most common adverse events.
- Circulating tumour DNA positivity after total neoadjuvant therapy showed significant prognostic value, with the positive status associated with worse distant relapse-free survival (P = .0032) and progression-free survival (P = .0028) among patients in the non-operative management group.
IN PRACTICE:
“Nonoperative management ensures excellent distant disease control with organ preservation after clinical complete response,” the authors wrote. “As a watch-and-wait approach becomes a recognised standard in international guidelines, the integration of ctDNA [circulating tumour DNA] and possibly other novel biomarkers, adds a crucial dimension to risk stratification and underscores the potential for personalised treatment approaches,” they added.
SOURCE:
This study was led by Alessio Amatu, MD, and Giorgio Patelli, MD, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy. It was published online in The Lancet Oncology .
LIMITATIONS:
This study was powered only to estimate 30-month distant relapse-free survival for the non-operative management group, potentially limiting statistical power for subgroup and molecular analyses. The single-arm design without randomisation did not directly address whether rectal surgery might provide added value in cases of clinical complete response. The specific induction-based total neoadjuvant therapy strategy used might not have fully reflected evolving practices. Additionally, the racial homogeneity of the study population limited generalisability beyond predominantly White populations.
DISCLOSURES:
This study was funded by Fondazione AIRC ETS, Fondazione Oncologia Niguarda ETS, Grande Ospedale Metropolitano Niguarda, Ministero della Salute, and AIRC 5xMille 2018. Several authors reported receiving grants or honoraria and having other ties with various sources. Full disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.A version of this article first appeared on Medscape.com.
TOPLINE:
Non-operative management achieved 95% distant relapse-free survival at 30 months in patients with stage II-III rectal cancer showing a clinical complete response to total neoadjuvant therapy, while maintaining successful salvage surgery options among 15% of those who experienced local regrowth according to a phase 2 trial.
METHODOLOGY:
- Researchers conducted an investigator-driven, multicentre, single-arm, phase 2 trial enrolling 180 patients (median age, 62 years; 44% women) with stage II-III adenocarcinoma of the lower-to-middle rectum across four cancer centres in Italy from June 2018 to August 2023.
- Treatment consisted of induction chemotherapy with 4 cycles of capecitabine (1000 mg/m2 orally twice daily on days 1-14 every 3 weeks) and oxaliplatin (130 mg/m2 intravenously on day 1 every 3 weeks), followed by chemoradiotherapy with 50-54 Gy in 25 fractions for 5 weeks.
- The analysis included 179 evaluable patients: 47 (26%) who achieved a clinical complete response were assigned to nonoperative management, 107 (60%) underwent surgery after therapy, and 18 (10%) underwent surgery after study discontinuation.
- The primary outcome was 30-month distant relapse-free survival in the non-operative management group, and secondary outcomes included local relapse-free or regrowth-free survival (local regrowth after non-operative management and local relapse after surgery).
TAKEAWAY:
- After a median follow-up of 35 months, 30-month distant relapse-free survival reached 95% in the non-operative management group vs 74% in the surgery group and 74% in the overall population.
- Among patients undergoing non-operative management, 15% experienced tumour regrowth in the rectal wall within 2 years, corresponding to a 2-year risk for local regrowth of 17%, and cumulative risks for local relapse were 11% at 2 years and 16% at 3 years among those in the surgery group.
- The most common adverse events of grade 3-4 were diarrhoea (4%), lymphopenia (4%), and neutropenia (4%). Overall, 17% of patients had a serious adverse event, with bowel obstruction (4%) and thromboembolism (3%) being the most common adverse events.
- Circulating tumour DNA positivity after total neoadjuvant therapy showed significant prognostic value, with the positive status associated with worse distant relapse-free survival (P = .0032) and progression-free survival (P = .0028) among patients in the non-operative management group.
IN PRACTICE:
“Nonoperative management ensures excellent distant disease control with organ preservation after clinical complete response,” the authors wrote. “As a watch-and-wait approach becomes a recognised standard in international guidelines, the integration of ctDNA [circulating tumour DNA] and possibly other novel biomarkers, adds a crucial dimension to risk stratification and underscores the potential for personalised treatment approaches,” they added.
SOURCE:
This study was led by Alessio Amatu, MD, and Giorgio Patelli, MD, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy. It was published online in The Lancet Oncology .
LIMITATIONS:
This study was powered only to estimate 30-month distant relapse-free survival for the non-operative management group, potentially limiting statistical power for subgroup and molecular analyses. The single-arm design without randomisation did not directly address whether rectal surgery might provide added value in cases of clinical complete response. The specific induction-based total neoadjuvant therapy strategy used might not have fully reflected evolving practices. Additionally, the racial homogeneity of the study population limited generalisability beyond predominantly White populations.
DISCLOSURES:
This study was funded by Fondazione AIRC ETS, Fondazione Oncologia Niguarda ETS, Grande Ospedale Metropolitano Niguarda, Ministero della Salute, and AIRC 5xMille 2018. Several authors reported receiving grants or honoraria and having other ties with various sources. Full disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.A version of this article first appeared on Medscape.com.